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Assessing the Impact of Mount Sinai Parenting Center's Newborn Class

2019年10月8日 更新者:Dani Dumitriu、Icahn School of Medicine at Mount Sinai

Accessing the Effectiveness of a Pediatrician-led Newborn Parenting Class on Maternal Newborn Care Knowledge, Anxiety and Confidence

This study is the first to evaluate the effectiveness of a Newborn Parenting Class designed by Mount Sinai Parenting Center. The study measures how effective the class is in improving maternal knowledge on newborn care, decreasing maternal self-perceived anxiety and increasing maternal confidence.

調査の概要

状態

完了

条件

詳細な説明

The important role positive parenting plays in promoting a child's developmental trajectory has led to the design and implementation of many postpartum education initiatives. With 99% of babies in the U.S. born in hospitals, there is a uniqueness of being in the hospital for an extended period of time with the opportunity to educate parents on the importance of promoting early development. Pediatricians are uniquely well-positioned to address both medical and developmental concerns parents may have during critical periods in a child's development, yet very few interventions are led by pediatricians. The Mount Sinai Parenting Center designed the Newborn Parent Education and Discharge Class (hereafter referred to as Newborn Class) to address this issue. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai. The class aims to educate parents about medical issues, responsive parenting, and sleep. It is currently taught every Tuesdays and Thursdays. Because of the limited availability of the class, not all mothers have the opportunity to attend. This research study will survey first time mothers of newborns to explore the effectiveness of attending the class. The study team hypothesizes that attending the class would result in increased knowledge on newborn care, increased confidence levels and decreased levels of anxiety.

First time mothers who delivered a full-term singleton vaginally with no major complications were included in the study. Only mothers who attended the class (intervention) or expressed desire to attend class but were discharged before a class was offered (control) were included in analysis. Mothers were recruited between May 2018 and August 2019 at the Klingenstein Pavilion of Mount Sinai. Maternal self-perceived anxiety and confidence were measured using standardized scales, and knowledge on newborn care was assessed using an internally-developed scale.

研究の種類

観察的

入学 (実際)

82

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • New York
      • New York、New York、アメリカ、10029
        • Mount Sinai Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

サンプリング方法

非確率サンプル

調査対象母集団

Participants of the study are mothers who delivered vaginally a singleton with no major perinatal complications at Mount Sinai Hospital. Participants were not randomized into control and intervention. This was an Observational study of eligible mothers than attended the Newborn Class ("intervention group") and eligible mothers who wanted to but were not able to attend the Newborn Class because it was not available during their stay at the hospital ("control group").

説明

Inclusion Criteria:

  • First-time mother
  • Above 18 years old
  • Vaginal delivery of a healthy full-term singleton
  • No major perinatal complications (per self-report)
  • Consent to participate.

Exclusion Criteria:

-none

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Newborn Parenting Class
New Mother who attended the Newborn Parenting Class
Newborn Parenting Class designed by Mount Sinai Parenting Center. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai.
New Mothers
New Mothers who expressed interest, but did not attend the Newborn Parenting Class

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
State-Trait Anxiety Inventory for Adults (STAI)
時間枠:Immediately after enrollment (Day 1)
Maternal self-perceived anxiety was measured using State-Trait Anxiety Inventory for Adults (State only). A 40 self-report items questionnaire, each item scored on 4-point likert-type response scale from 1 (not at all) to 4 (almost always), full range from 20 to 80, with higher score STAI scores suggesting higher levels of anxiety
Immediately after enrollment (Day 1)
Karitane Parenting Confidence Scale (KPCS)
時間枠:Immediately after enrollment (Day 1)
Confidence level was measured using Karitane Parenting Confidence Scale. A 15 item instrument with ach item on the KPCS is scored 0, 1, 2, or 3. Total score range from 0-45, with higher score indicating the parent feeling more confident.
Immediately after enrollment (Day 1)
Newborn Care Knowledge Questionnaire
時間枠:Immediately after enrollment (Day 1)

Knowledge on newborn care was assessed using an internally-developed scale, developed by a team of pediatricians and specialists.

Total score ranges from 0-10, with higher score indicating higher level of knowledge.

Immediately after enrollment (Day 1)

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • 主任研究者:Dani Dumitriu, MD, PhD、Columbia University Irving Medical Center; Icahn School of Medicine at Mount Sinai
  • 主任研究者:Blair S Hammond, MD、Icahn School of Medicine at Mount Sinai

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2018年5月28日

一次修了 (実際)

2019年8月2日

研究の完了 (実際)

2019年8月2日

試験登録日

最初に提出

2019年10月7日

QC基準を満たした最初の提出物

2019年10月8日

最初の投稿 (実際)

2019年10月9日

学習記録の更新

投稿された最後の更新 (実際)

2019年10月9日

QC基準を満たした最後の更新が送信されました

2019年10月8日

最終確認日

2019年10月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

育児介入の臨床試験

Newborn Parenting Classの臨床試験

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